The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.

sensory, proprioceptive training in foot position and degree of plantarflexion or dorsiflexion

no electric stimulation (e-stim) will be utilized

Experimental: Dynasplint

Patients in the experimental Dynasplint group will be treated with the current standard of care, including onabotulinum toxin, and use the Ankle Dorsiflexion Dynasplint

Device: Ankle Dorsiflexion Dynasplint

Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or "Experimental" group will add this therapy to their standard of care regimen

Other Name: ADFD, AFD

Eligibility

Ages Eligible for Study:

18 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients enrolled will be male or female, be at least 18 years of age, and have been diagnosed with spastic hemiplegia and excessive plantarflexion, which includes the following:

Diagnosis of a stroke or traumatic brain injury more than 6 months prior to enrollment in this study

Subjects currently using aminoglycoside antibiotics, curare-like agents, or other agents that may interfere with neuromuscular function

Subjects with profound weakness or atrophy of the muscles in the target areas of injection

Active systemic infection or infection at the injection site

Allergy or sensitivity to botulinum toxin A

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329705